Icon-facebook Twitter Youtube Linkedin

Reverse engineering of Formulation (Tablet, Capsules, Gel or Cream)

Reverse Engineering of Formulations

Q1/Q2/Q3 Sameness for Tablets, Capsules, Gels & Creams

Overview Service

Capzer Pharmaceuticals reverse engineers reference listed drugs (RLDs) to achieve qualitative (Q1), quantitative (Q2), and physicochemical (Q3) sameness for generic ANDA development. Our FDA/DEA-registered cGMP laboratory deconstructs tablets, capsules, gels, and creams using HPLC, Raman, and SEM to identify APIs, excipients, and manufacturing processes for Empagliflozin and complex generics.

Reverse Engineering Process

Systematic deformulation reveals complete formulation blueprint.

  • Disassembly: Milling, coating removal, core extraction for tablets/capsules.

  • API/Quantitative: HPLC-UV/MS for potency, impurity profiles matching RLD.

  • Excipient Identification: FTIR/Raman microscopy, NMR for binders, polymers, lubricants.

Dosage Form Capabilities

Tailored methods ensure physical/process equivalence.

  • Tablets: Aqueous extraction, dissolution matching f2>50, granulation clues via SEM.

  • Capsules: Shell analysis (gelatin/HPMC), fill powder profiling.

  • Gels/Creams: Emulsion phase separation, rheology, preservative assay.​

Key Techniques

  • Microscopy: SEM/XRPD for particle morphology, polymorphism.
  • Thermal: DSC/TGA for polymer ratios, moisture content.
  • Spectroscopy: Raman mapping for API distribution, coating thickness.

Benefits for Partners

Partners secure ANDA-ready Q1/Q2/Q3 reports from our ISO 17025 facility, enabling first-cycle approval for Gabapentin commercialization and Empagliflozin scale-up.

Other Service

Need for help?

Our expert team is here to support you with reliable pharmaceutical testing, analytical solutions, and regulatory guidance. Whether you have a query or need a customized service, we’re ready to assist you at every step.

Contact Us